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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 24F X 2.4 CM BUTTON KIT; FEEDING DEVICE
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BARD ACCESS SYSTEMS 24F X 2.4 CM BUTTON KIT; FEEDING DEVICE Back to Search Results
Model Number 000286
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that after some days (time unknown) of a feeding device button installment, there was an alleged leak between the button and the extensions.It was further reported that the extensions allegedly leaked for approximately four days.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria, this is the first complaint reported for this lot number and general issue to date.Investigation summary: one 24 fr x 2.4cm button kit was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for leaking at adaptor extensions, as leaking was observed at both large tube straight adapters and the small tube straight adapter when the sample was infused against resistance.No obvious damage was observed on the hole and adapter surfaces and no obvious abnormalities in the measured diameters were observed.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Labeling review:a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that after some days (time unknown) of a feeding device button installment, there was an alleged leak between the button and the extensions.It was further reported that the extensions allegedly leaked for approximately four days.There was no reported patient injury.
 
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Brand Name
24F X 2.4 CM BUTTON KIT
Type of Device
FEEDING DEVICE
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7898853
MDR Text Key121456441
Report Number3006260740-2018-02538
Device Sequence Number1
Product Code KGC
UDI-Device Identifier10801741087896
UDI-Public(01)10801741087896
Combination Product (y/n)N
PMA/PMN Number
K904779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number000286
Device Catalogue Number000286
Device Lot NumberHUAT1462
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2019
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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